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Study Evaluating Intravitreal hI-con1™ in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration
Not Recruiting
Trial ID: NCT02358889
Purpose
The purpose of this study is to evaluate the safety, biological activity and pharmacodynamic
effect of repeated intravitreal doses of hI-con1 0.3 mg administered as monotherapy and in
combination with ranibizumab 0.5 mg compared to ranibizumab 0.5 mg monotherapy in treating
patients with choroidal neovascularization (CNV) secondary to age-related macular
degeneration (AMD).
Official Title
A Phase 2 Randomized, Double-masked, Multicenter, Active-controlled Study Evaluating Administration of Repeated Intravitreal Doses of hI-con1™ in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration
Stanford Investigator(s)
Theodore Leng, MD, FACS
Associate Professor of Ophthalmology and, by courtesy, of Anesthesiology, Perioperative and Pain Medicine (Adult MSD)
Eligibility
Inclusion Criteria:
- Males or females of any race at least 50 years of age
- Active primary Choroidal Neovascularization (CNV) secondary to Age-Related Macular
Degeneration (AMD) in the study eye
- Best Corrected Visual Acuity (BCVA) of 70 to 24 letters (worse than 20/40 up to
20/320) in the study eye
Exclusion Criteria:
- Monocular patient or patient with a BCVA of 35 or fewer letters (20/200 or worse) in
the better seeing eye
- Any prior treatment of CNV or advanced AMD in the study eye, except for dietary
supplements or vitamins
- Any intraocular or ocular surface surgery (including cataract surgery and laser
procedures) in the study eye within 3 months
- Vitrectomy in the study eye
- Hereditary or chronic hemorrhagic or coagulopathy conditions (i.e., hemophilia)
Intervention(s):
biological: hI-con1
biological: ranibizumab
other: Sham injection
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305